+34 932917739 - Tecno-med Ingenieros SL NIF: ES B60945292 info@tecno-med.es

El Organismo Notificado español AEMPS ha comunicado en nota de prensa su renovación de la notificación como Organismo Notificado según la directiva 93/42/EEC acreditada por ENAC. La notificación aparece en NANDO con fecha 4 de Julio de 2018: http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&refe_cd=EPOS_43640
Estos son los códigos para los que esta notificado el ON 0318:

Products Procedures Articles/Annexes Limitations
*MD 0100 – General non-active, non-implantable medical devices
   – *MD 0101 – Non-active devices for anaesthesia, emergency and intensive care EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0102 – Non-active devices for injection, infusion, transfusion and dialysis EC type-examination
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex II
Annex V
Annex VI
Annex III limitated to punture, injection and/or extraction of fluids medical devices
   – *MD 0103 – Non-active orthopaedic and rehabilitation devices EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0104 – Non-active medical devices with measuring function EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0105 – Non-active ophthalmologic devices EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0106 – Non-active instruments EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0107 – Contraceptive medical devices EC type-examination
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex II
Annex V
Annex VI
Annex III limitated to male latex condoms
   – *MD 0108 – Non-active medical devices for disinfecting, cleaning, rinsing EC type-examination
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex II
Annex V
Annex VI
Annex III limitated to contact lenses care products
   – *MD 0109 – Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0110 – Non-active medical devices for ingestion EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
*MD 0200 – Non-active implants
   – *MD 0201 – Non-active cardiovascular implants EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Limitated to stents
   – *MD 0202 – Non-active orthopaedic implants EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0203 – Non-active functional implants EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Excluding neurological and neurosurgical implants
   – *MD 0204 – Non-active soft tissue implants EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Excluding breast implants
*MD 0300 – Devices for wound care
   – *MD 0301 – Bandages and wound dressings EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0302 – Suture material and clamps EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0303 – Other medical devices for wound care EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
*MD 0400 – Non-active dental devices and accessories
   – *MD 0401 – Non-active dental equipment and instruments EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0402 – Dental materials EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 0403 – Dental implants EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
*MD 1100 – General active medical devices
   – *MD 1101 – Devices for extra-corporal circulation, infusion and haemopheresis EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Excluding infusion pumps for the delivery of medicines
   – *MD 1102 – Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 1103 – Devices for stimulation or inhibition EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 1105 – Active ophthalmologic devices EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Limitated to diagnostic medical devices
   – *MD 1106 – Active dental devices EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 1107 – Active devices for disinfection and sterilisation EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 1108 – Active rehabilitation devices and active prostheses EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 1111 – Software EC declaration of conformity (full quality assurance system) Annex II
   – *MD 1112 – Medical gas supply systems and parts thereof EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
*MD 1200 – Devices for imaging
   – *MD 1201 – Imaging devices utilising ionizing radiation EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Limitated to X-ray medical devices and gamma cameras
*MD 1300 – Monitoring devices
   – *MD 1301 – Monitoring devices of non-vital physiological parameters EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
   – *MD 1302 – Monitoring devices of vital physiological parameters EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
*MD 1400 – Devices for radiation therapy and thermo therapy
   – *MD 1402 – Devices utilising non-ionizing radiation EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Limitated to microwave and magnetotherapy medical devices
Horizontal technical competence Limitations
*MDS 7001 – Medical devices incorporating medicinal substances, according to Directive 2001/83/EC
*MDS 7004 – Medical devices referencing the Directive 2006/42/EC on machinery
*MDS 7006 – Medical devices in sterile condition Including aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma x-ray, electron beam), sterilisation with hydrogen peroxide, thermic sterilisation with dry heat.
*MDS 7009 – Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed
*MDS 7010 – Medical devices incorporating software /utilising software /controlled by software